Effect of the Clean Bench Configuration Environment on Cleanliness during Intravenous Hyperalimentation Infusion Preparation

Abstract

When mixing and compounding injectable agents, performing aseptic manipulations on a clean bench maintained according to the requirements of the US Federal Standard Class 100 (≤100 pcs/ft³) is crucial for the prevention of contamination by airborne particulates or microbes. Owing to air turbulence generated by the compounding manipulations and other factors, the level of cleanliness in the clean bench may be affected by the configuration environment. We configured clean benches in different environments with mean airborne particulate counts of (A) 1,000, (B) 30,000, and (C) 300,000/ft³ and with the sash opened to 20 and 40 cm and measured the amount of particulate matter and microbes when preparing intravenous hyperalimentation infusions. For the particulate count, Class 100 was maintained in all configuration environments when the sash was opened to 20 cm, but Class 100 was not maintained in any of the environments when the sash was opened to 40 cm. When the sash was opened to 20 cm, no microbes were detected; however, at 40 cm, microbes were detected in all environments, with the level exceeding the NASA reference range (≤0.1 pcs/ft³) in environment C. Therefore, the configuration environment of the clean bench and size of the sash opening impact the level of cleanliness regarding the amount of particulate matter and microbes in a clean bench. This study prescribes conditions necessary for maintaining cleanliness in clean benches from an air cleanliness perspective when pharmacists are mixing and compounding injectable agents in hospital wards or pharmacies.